Fitbit Tracking for Post-Surgery Ambulation

Recruiting at 1 trial location

Overseen By Anupama Singh, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Non-ambulatory, Cognitive disease, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how tracking daily steps with a Fitbit (specifically, the Fitbit Inspire) can help understand exercise levels in patients over 65 preparing for thoracic surgery. The goal is to gather data on patients' walking activity before their operation. Participants will wear a Fitbit for one week before their surgery and log their daily steps. This trial is ideal for those who are mobile and planning surgery at Brigham and Women's Hospital. Those unable to walk or requiring urgent surgery are not eligible. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance pre-surgery care for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Fitbit Inspire is safe for post-surgery ambulation tracking?

Research has shown that using the Fitbit Inspire to track physical activity is safe for patients. This device is an easy-to-use, affordable tool that records activity levels without causing harm. Studies have found that tracking steps with the Fitbit can help assess patients' status before surgery. No major side effects from wearing the Fitbit have been reported, indicating that users generally tolerate it well. The Fitbit Inspire is commonly used in similar studies and has a good safety record, making it a reliable choice for tracking patient activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fitbit Inspire trial for post-surgery ambulation because it introduces a new way to encourage and monitor patient movement after surgery. Unlike traditional methods that rely on general advice and periodic check-ins, the Fitbit provides real-time feedback and motivation by tracking steps daily. This tech-driven approach could improve patient engagement and recovery outcomes by offering a personalized and interactive experience. By allowing patients to see their progress and receive timely support, the Fitbit Inspire could revolutionize how we approach post-surgical care.

What evidence suggests that using Fitbit Inspire is effective for tracking ambulation in post-surgery patients?

Research shows that using a Fitbit to track steps after surgery can aid recovery. This trial provides participants with a Fitbit device to track their steps for one week before their scheduled surgery. Studies have found that walking soon after surgery can speed up recovery, lower the risk of blood clots, and reduce hospital stays. Fitbit devices accurately count steps, helping patients stay active. For example, in cases of complex appendicitis, Fitbit-based models identified 83% of all post-surgery issues, proving their usefulness in monitoring recovery. By tracking daily steps, patients may improve their recovery after surgery. ^{4 6 7 8 9}

Who Is on the Research Team?

Michael T Jaklitsch, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older who are scheduled for major lung surgery at Brigham and Women's Hospital. They must be able to walk and give consent, without urgent cardiac diseases that need testing or surgeries so immediate they can't wait for the study period.

Inclusion Criteria

I am 65 or older and will have chest surgery at Brigham and Women's Hospital.

Exclusion Criteria

My surgery needs to happen sooner than the trial's required timeframe.

I have heart problems that need testing before I can join.

I cannot walk and use a wheelchair for mobility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Exercise Tracking

Participants use a Fitbit to track daily steps for 1 week prior to surgery. They keep a log of their steps and receive a progress check-in call.

1 week

1 visit (in-person), 1 call (virtual)

Follow-up

Participants return the step-tracker and log either at a pre-surgery clinic visit or on the day of surgery.

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit Inspire

Trial Overview

The study is tracking how many steps patients over 65 take each day using a Fitbit Inspire before undergoing thoracic surgery. The goal is to collect data on their physical activity levels prior to the operation.

How Is the Trial Designed?

Group I: PRE-OPERATIVE EXERCISE TRACKING Experimental Treatment 1 Intervention

Participant baseline information will be collected from their electronic medical records. After enrollment, participants will be provided a mobile device (Fitbit) to wear for tracking steps for 1 week prior to their scheduled surgery. Participants will keep a log of daily steps for the 1 week they are wearing the device and receive one progress check-in call during the week. The device and log will be turned in either on a pre-surgery clinic visit or on the day of surgery whichever comes first.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

The study involved nine participants with transfemoral amputations and used a Fitbit activity monitor to assess their mobility over one week, showing that activity levels correlated with their functional ability as classified by K levels.

The Fitbit activity score provided consistent insights into activity levels that were independent of individual factors like age, weight, and height, suggesting it could be a valuable tool for monitoring prosthetic use in everyday settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring daily function in persons with transfemoral amputations using a commercial activity monitor: a feasibility study. Albert, MV., Deeny, S., McCarthy, C., et al.[2014]

The Fitbit Flex activity monitor was found to be an invalid measure of step count and distance walked in post-cardiac surgery patients, based on a study involving 20 participants.

There was a significant discrepancy between the Fitbit outputs and manual measurements, indicating that the device should not be used as a clinical tool for monitoring walking progression in the early postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Fitbit Flex in an Acute Post-Cardiac Surgery Patient Population. Daligadu, J., Pollock, CL., Carlaw, K., et al.[2020]

The use of accelerometers to monitor physical activity in children after surgery is feasible, with 25 out of 60 enrolled patients successfully completing the study, providing objective data on recovery.

Recovery trajectories differ between inpatient and outpatient procedures, with outpatient patients returning to preoperative light physical activity levels by day 7 and moderate-to-vigorous activity peaking at 90% by day 8, while inpatient patients showed slower recovery rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using accelerometers to characterize recovery after surgery in children. Ghomrawi, HM., Baumann, LM., Kwon, S., et al.[2018]

A study involving 66-118 patients who underwent weight loss surgery showed that post-operative weeks were linked to decreased daily steps, less time spent walking, and improved sleep metrics, indicating significant lifestyle changes after surgery.

The research highlights the effectiveness of consumer-grade wearable devices, like Fitbits, in monitoring behavioral and physiological changes during recovery, suggesting they could be valuable tools for tracking patient progress in a convenient and continuous manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Digital Assessment for Weight Loss Surgery Patients. Ramirez, E., Marinsek, N., Bradshaw, B., et al.[2020]

Using consumer-based activity monitors (CAMs) during the perioperative period for patients undergoing major oncologic surgery is feasible, with 86% of participants providing analyzable data.

Despite high compliance before surgery, the significant drop in activity levels (77% reduction in daily steps) post-surgery suggests that CAMs could help identify patients at risk for postoperative complications, although traditional measures of functional status may not effectively capture these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of low-cost accelerometers in measuring functional recovery after major oncologic surgery. Barkley, R., Khalil, M., Shen, P., et al.[2023]

In a study of 30 patients using Fitbit devices after head and neck surgery, those who took at least 200 steps on the first postoperative day had a significantly shorter hospital stay (4.5 days vs. 7.2 days).

The study found that wearable activity devices are effective for monitoring ambulation and sleep trends post-surgery, suggesting they could enhance recovery by providing valuable data on patient activity and sleep patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring postoperative ambulation and sleep after head and neck surgery: Feasibility and utility study using wearable devices. Pandrangi, VC., Jorizzo, M., Shah, S., et al.[2022]

The study found that the Fitbit activity monitor showed moderate-to-good correlation with the SenseWear Armband, a reference standard accelerometer, for measuring steps and energy expenditure in 47 participants six months after total knee arthroplasty (TKA).

In contrast, the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire had poor-to-moderate correlation with the accelerometer, suggesting it may underestimate daily energy expenditures compared to more objective measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of Tools to Measure Physical Activity in Older Adults Following Total Knee Arthroplasty. Jasper, L., Beaupre, LA., Spence, JC., et al.[2022]

The study tracked the recovery of 66 children who underwent the modified Nuss procedure using Fitbit step counts, revealing a steady increase in daily activity that plateaued around day 18 post-surgery.

This objective recovery trajectory can help set realistic expectations for patients and caregivers, potentially reducing unnecessary healthcare visits and improving post-discharge management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer Wearables Define a Normative Recovery Trajectory Following the Modified Nuss Procedure. Carter, M., Linton, S., Zeineddin, S., et al.[2023]

The study involved 48 patients recovering from elective colorectal procedures, and it aimed to see if activity trackers with alarms would increase their postoperative ambulation.

Despite the use of trackers with alarms, there was no significant increase in daily steps compared to trackers without alarms, indicating that while tracking ambulation is useful, alarms alone may not enhance postoperative activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Activity Trackers With vs. Without Alarms to Increase Postoperative Ambulation: A Randomized Control Trial. Waller, GC., Kim, TG., Perez, S., et al.[2021]

The study involved 26 children aged 3-18 who underwent appendectomy, using the FitBit Inspire HR to track their recovery over 21 days, revealing that those with simple appendicitis showed a faster recovery trajectory compared to those with complicated appendicitis.

Wearable technology like FitBit can effectively characterize postoperative recovery in children and differentiate recovery patterns based on the severity of the condition, potentially aiding in the early detection of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Wearable Sensors to Assess Postoperative Recovery in Pediatric Patients After Appendectomy. De Boer, C., Ghomrawi, H., Many, B., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11536558/

Accuracy of wrist-worn activity trackers for measuring steps in ...

To examine the accuracy of wrist-worn activity trackers to measure steps of patients in early mobilization after major abdominal surgery.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02833324

NCT02833324 | Fitbit for Postoperative Ambulation

Early mobilization after surgery has been shown to reduce recovery time, incidence of venous thromboembolism, length of hospital stay and both pulmonary and ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10432429/

Applying machine learning to consumer wearable data for ...

Fitbit-based models are more effective for patients with complicated appendicitis, detecting 83% of all postoperative events in this cohort.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02741895

Using Fitbit to Monitor Ambulation in Patients After Surgery.

After the patient is awake and alert after surgery, a study team member will place the Fitbit device on participants' wrists.

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/lary.31989

Postoperative Implementation of Virtual Reality and ...

Objective. To examine implementation of virtual reality (VR) and Fitbit wearable activity devices in postoperative recovery.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10141298/

Fitbit Data to Assess Functional Capacity in Patients Before ...

The aim of this study was to present and evaluate the possibility of using commercial smartwatch data, such as those retrieved from the Fitbit Inspire 2 device,

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9955976/

Wearable Health Technology for Preoperative Risk ...

In this pilot study, we demonstrated that a simple, low-cost device can be used to track patient home activity over several days before surgery, ...

8.

nature.com

nature.com/articles/s41746-023-00890-z

Applying machine learning to consumer wearable data for ...

Fitbit-based models are more effective for patients with complicated appendicitis, detecting 83% of all postoperative events in this cohort.

9.

academic.oup.com

academic.oup.com/bjsopen/article/6/2/zrac031/6564495

Wearable devices to monitor recovery after abdominal surgery

Wearable devices have been proposed as a novel method for monitoring patients after surgery to track recovery, identify complications early, and improve ...